Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00407758
First received: December 4, 2006
Last updated: July 18, 2012
Last verified: May 2007
  Purpose

RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: enzastaurin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of PFS and overall survival [ Designated as safety issue: No ]
  • Prognostic factors, including platinum sensitivity, initial performance status, and age [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: November 2006
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

  • Determine the duration of progression-free and overall survival of patients treated with this regimen.
  • Determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Recurrent or persistent disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • Must have ≥ 1 target lesion to assess response

      • Tumors within a previously irradiated field are designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
  • Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease

    • Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment
    • Must meet any 1 of the following criteria for platinum-based therapy:

      • Disease progression during therapy
      • Treatment-free interval after completion of treatment < 12 months
      • Disease persistence after completion of therapy
  • Ineligible for a higher priority GOG clinical trial

PATIENT CHARACTERISTICS:

  • GOG performance status 0-1 (for patients who received 2 prior treatment regimens) OR 0-2 (for patients who received 1 prior treatment regimen)
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL (transfusions allowed)
  • Creatinine < 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN
  • Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Able to swallow tablets
  • No sensory or motor neuropathy > grade 1
  • No active infection requiring antibiotics
  • No other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer
  • No serious systemic disorders that would preclude study compliance, including an abnormal ECG indicative of cardiac disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior anticancer hormonal therapy
  • No more than 1 additional cytotoxic regimen for management of recurrent or persistent disease
  • At least 4 weeks since other prior anticancer therapy, including immunotherapy
  • At least 30 days since prior investigational drugs
  • No prior enzastaurin hydrochloride
  • No prior radiotherapy to > 25% of marrow-bearing areas
  • No prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease
  • No prior treatment that would preclude treatment on this protocol
  • No concurrent chemotherapy, immunotherapy, or other experimental medications
  • No concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin
  • No other concurrent systemic anticancer therapy
  • No concurrent radiotherapy, including palliative radiotherapy
  • No concurrent agents that stimulate thrombopoiesis
  • No concurrent amifostine or other protective reagents
  • Concurrent hormone replacement therapy allowed
  • Concurrent bisphosphonates allowed provided bony metastases are present
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407758

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Lydia Usha, MD Rush University Medical Center
Investigator: Jean A. Hurteau, MD NorthShore University HealthSystem Research Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00407758     History of Changes
Other Study ID Numbers: CDR0000517318, GOG-0170J, LILLY-H6Q-MC-S025
Study First Received: December 4, 2006
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 01, 2014